Newsletter Life Sciences and Healthcare

Newsletter 2/2017

Life Sciences and Healthcare

1. Regulatory changes leave more drugs prescription free

As of New Year’s 2018, some drugs that today are subject to prescription will become prescription free at the pharmacy. Regulatory changes leave for instance the cholesterol lowering drug simvastatin, triptans against migraines and high dosages of ibuprofen, prescription free, but subject to pharmacist’s control. The pharmacist control comprises extended guidance on how to use the drugs and after having checked off different check-lists etc. This contrary to the description free drugs from the pharmacies’ shelf-selection, where guidance from pharmacists are subject to request.

The new category of prescription free drugs shall be placed behind the pharmacy counter and will be categorized as pharmaceuticals subject to risk-minimisation. The categorisation will appear on the MA issued by the Norwegian Medicines Agency.

The easier access to drugs is meant to empower patients to make informed choices in prevention, self-diagnosis and treatment of diseases and disability. At the same time health personnel’s capacity will be released by ensuring good guidance on use through the pharmacies.

The new regimen is founded in amendments to the Pharmacy Regulations and Regulations on the Procurement and Delivery from Pharmacies.

2. Amsterdam will be the new host of the European Medicines Agency

The European Medicines Agency (EMA), today located in London, UK, will as a consequence of the Brexit referendum relocate to a new location within the EU.

As EMA is not only seen as prestigious, but brings a regular flow of visitors to boost local hotels and businesses, 19 EU countries asked for the opportunity to host the new EMA. On the 20 November 2017 the European Council decided by vote; EMA will move to Amsterdam. EMA has already started working with the Dutch government to ensure a successful move by end of March 2019.

3. Is the colour purple on GlaxoSmithKline`s inhalers a trademark?

The Norwegian Pharmacy Association, represented by DIFA AS, has on behalf of the Norwegian pharmacies and the pharmacy chains entered into an agreement with Capgemini concerning the development of a new system for digital communication between pharmacies and the public health services. The system shall represent a digital renewal for the industry and also make it easier for the pharmacies to comply with applicable rules and regulations. The new system will replace today’s IT-system, FarmaPro. The agreement has an assumed value of NOK 430 million. Kvale has in this regard assisted the pharmacy chain Boots.

On 11 July 2017 the Oslo District Court gave judgement in a patent dispute between Actelion Pharmaceuticals Ltd. v. Icos Corporation. The dispute concerned the validity of Icos Corporation`s Norwegian Patent NO 321 602 which pertains to tadalafil with a specified particle size. The specific particle size was obtained through so-called micronisation.

Tadalafil is the generic name of the active ingredient of the prescription drug Cialis for the treatment of erectile dysfunction (impotence) and Adcirca, for the treatment of pulmonary arterial hypertension (high blood pressure in the pulmonary vasculature). Tadalafil was a known compound at the priority date of the patent.

The issue before court was whether micronisation of tadalafil to obtain the specified particle size, fulfilled the patentability requirement of inventive step.

The Oslo District Court concluded that the patent was invalid because the person skilled in the art would have arrived at the method of micronising tadalafil and would have used this method to improve absorption and bioavailability. Hence, Icos Corporation`s Norwegian patent did not exhibit a sufficient inventive step.

5. The Norwegian pharmacies joins forces to acquire a new IT-system

The Norwegian Pharmacy Association, represented by DIFA AS, has on behalf of the Norwegian pharmacies and the pharmacy chains entered into an agreement with Capgemini concerning the development of a new system for digital communication between pharmacies and the public health services. The system shall represent a digital renewal for the industry and also make it easier for the pharmacies to comply with applicable rules and regulations. The new system will replace today’s IT-system, FarmaPro. The agreement has an assumed value of NOK 430 million. Kvale has in this regard assisted the pharmacy chain Boots.

6. News from Kvale

Kvale’s Life Sciences & Healthcare team keeps on specialising and growing.

In September 2017 partner Ingvild Hanssen-Bauer joined Kvale’s Life Sciences & Healthcare team. Ingvild came from the law firm Wikborg Rein in Oslo. She specialises in intellectual property rights, especially patent litigation, and has over 20 years of experience from the field. Ingvild is highly ranked within her field of expertise, and has a strong track record in patent litigation for pharmaceutical companies. In addition we will have two new associates joining our team from New Year.

These latest hires will expand our team to 16 practitioners by January 2018, with a core group consisting of seven partners. This makes Kvale one of the largest team of highly experienced Life Sciences & Healthcare lawyers in Norway.

The Kvale- team holds lectures, contributes and participates in relevant international forums such as i.a. LES International (Licensing Executives Society), the European Pharma Law Academy (365Knect) and will also attend the general assembly and annual conference of EPLAW (European Patent Lawyers Association) in Brussel in November.